X-ray Flat Panel Detectors (EverestView 4343X)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K223687 FDA 510(k)
- FDA Product Code
- MQB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EverestView 4343X is a Solid State X-Ray Imager (Flat Panel/Digital Imager), a digital detector designed for capturing high-resolution radiographic images. It employs a scintillator matrix with a pixel pitch of 100 µm and an imaging area of 17″ x 17″, converting X-ray exposure into digital signals for diagnostic imaging in radiology.
This device is supplied as a tethered flat panel detector, intended for use in radiology settings. It is classified as a Class II medical device under FDA regulation 892.1680 and has received FDA 510K clearance and MDR authorization. The detector’s dimensions are 46.0 x 46.0 x 1.5 cm, with a reported DQE performance exceeding 60% at 0 lp/mm, ensuring high-quality imaging for clinical applications.
Frequently asked questions
What is the EverestView 4343X primarily used for in clinical settings?
The EverestView 4343X is a Solid State X-Ray Imager (Flat Panel/Digital Imager) designed for capturing high-resolution radiographic images in radiology departments. Its 17" x 17" imaging area and 100 µm pixel pitch enable detailed digital X-ray imaging, making it suitable for general radiographic procedures where high-quality diagnostic images are required.
Is the EverestView 4343X single-use or reusable, and how should it be handled?
The EverestView 4343X is not explicitly described as single-use or reusable in the provided data. However, as a tethered flat panel detector, it is typically designed for repeated use in controlled clinical environments with appropriate cleaning and maintenance protocols. Manufacturers usually provide guidelines for disinfection and storage to ensure longevity and performance.
What are the physical dimensions and imaging performance specifications of the EverestView 4343X?
The EverestView 4343X has physical dimensions of 46.0 cm x 46.0 cm x 1.5 cm, making it a compact yet large-format detector. Its imaging performance includes a scintillator matrix with a 100 µm pixel pitch and an imaging area of 17" x 17", along with a Detective Quantum Efficiency (DQE) exceeding 60% at 0 line pairs per millimeter (lp/mm), ensuring high image quality for diagnostic radiography.
How is the EverestView 4343X supplied, and what regulatory pathways has it undergone?
The EverestView 4343X is supplied as a tethered flat panel detector, meaning it connects to a system for image capture and processing. Regulatory-wise, it has received FDA 510K clearance (under K223687) and MDR authorization, confirming compliance with both U.S. and European Union medical device regulations. It is classified as a Class II device under FDA regulation 892.1680.
What types of radiology procedures would benefit most from using the EverestView 4343X?
The EverestView 4343X is ideal for general radiographic imaging where high-resolution digital images are critical, such as orthopedic evaluations, chest X-rays, abdominal imaging, and musculoskeletal studies. Its large 17" x 17" imaging area and high DQE performance make it well-suited for capturing detailed images of larger body parts or complex anatomical regions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K223687 - X-ray Flat Panel Detectors (EverestView 4343X), X-ray Flat Panel Detectors (EverestView 4343X)… - FDA.report, CareRay EverestView4343X - Tethered Flat Panel Detector
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K223687 | Class II | Active |
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Manufacturer
- Manufacturer
- Careray Digital Medical Technology Co., Ltd.
Sources (2)
- FDA 510(k) K223687 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026